26/04/2022
[PharmLife: Off-Label Uses]
What does Off-Label Use mean?
You may not realize that you have probably been prescribed a drug "off-label" at one time or another by your doctor. But what does "off-label" really mean? "Off-label" use of a drug refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the package labeling of the drug. It's common, and it's legal.
It is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
The package insert (or label) describes what the drug is, how it's used, important approval research, and possible side effects. In a study published in JAMA Internal Medicine, researchers found roughly 1 in 10 prescriptions were written for off-label use, and of those, 80% were for uses lacking strong scientific evidence.
An example of an Off-Label Use:
Quetiapine (Also known as Seroquel) is an Atypical Antipsychotic medication (2nd Generation) used for the treatment of Schizophrenia, Bipolar Disorder, and Major Depressive Disorder (MDD). It is sometimes used off-label, often as an augmentation agent, to treat conditions such as Tourette syndrome, musical hallucinations and anxiety disorders. Many people also use this drug as a sleeping aid, but the side effects can far outweigh the benefits.
"Off-label prescribing means that we're venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective," said Randall Stafford, MD, PhD, an associate professor with the Stanford Prevention Research Center.